Semaglutide 5 mg vials recalled for lack of sterility assurance
ProRx is recalling 2,805 vials of Semaglutide Injection 5 mg/2 mL from one lot for lack of assurance of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a loss of sterility assurance in an injectable creates an infection risk, and no injuries are reported.
Plain-English summary
Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), in 2 mL multidose vials for subcutaneous use, compounded by ProRx of Exton, Pennsylvania, is being recalled for lack of assurance of sterility.
The recall covers 2,805 vials from lot PRORX052125-4, carrying NDC 84139-225-02, distributed in Texas and Utah. The FDA has classified the recall as Class II.
Sterility matters for an injectable because the product is administered directly into the body. The enforcement record describes a loss of sterility assurance rather than confirmed contamination, and reports no injuries.
Patients and providers holding the affected lot should stop using it and contact the firm or their prescriber.
The recalled product
- Product
- Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02
- Manufacturer
- ProRx LLC
- Category
- Drug — Injectable
- Hazard
- sterility-assurance
- infection-risk
- compounded
- injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot PRORX052125-4
Distribution
Distributed in 2 states:
- TX
- UT
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